Getting Certified & Implementing Laboratory Accreditation ISO 17025
How does Process of Accreditation work?
Under ISO/IEC 17025, the quality of a laboratory is ensured by a method of on-site assessment and involvement in relevant Proficiency Testing programs. The on-site evaluation process is a thorough examination of the Management System and Quality System for the laboratory. All elements of the quality system addressed under ISO 9001 certification are covered. It also examines all the technical factors necessary to produce the quality data, including:
- Employee technological competence
- Validity and suitability of research methods
- Suitability of test equipment, calibration and maintenance
- Quality monitoring of the calibration and evaluation results
- Documents and record keeping
The on-site assessment method means the laboratory can generate reliable, traceable, and reproducible results. The method is replicated at frequent intervals to insure that its capacities are preserved by the laboratory. It is a very complex process performed by an accreditation body’s team of professional experts.
What are the advantages synonymous with accreditation under ISO / IEC 17025?
ISO / IEC 17025 is a norm framework for quality enhancement and self-correction. A laboratory benefits from ISO / IEC 17025 in the following ways:
- This improves the reliability of laboratory-generated test results
- This may develop technological integrity in the event of a matter of conjecture and/or validity
- Laboratory performance improves, consumer concerns decline, the laboratory achieves a clear competitive advantage and running expenses decline
The regulation facilitates the traceability of measurements and calibrations to optimum standards, establishes personnel technical competence, maintains a record of test equipment, ensures the accuracy of test results, the validity and correctness of test and calibration methods, proper handling and movement of test items, and the quality of the test environment and sampling.
What to look out for when getting certified
Each laboratory that pursues accreditation under ISO / IEC 17025 must be conscious of the complexities in measuring confusion within the accreditation group. As mentioned earlier on our website, ambiguity in measuring is the No.1 pitfall; however, accreditation authorities also lead to further decrease uncertainty.
The first question to be answered as measurement inconsistencies need to be decided will be, “Measurement ambiguity of what?” Accreditation organizations have not yet defined precise criteria about what measurement uncertainties would reflect. Some accreditation bodies have developed the best measurement uncertainty criteria for accreditation scopes, but most calibration laboratories still show measurement uncertainty on certificates or reports issued. The reported inconsistencies on certificates or records are in most situations highly inconsistent. Some uncertainties represent the best uncertainty of measurement, some of the worst uncertainty of measurement, and some of the uncertainty of test-point measurement.
In ISO / IEC 17025 you should be mindful of the secret specifications as well. Some of the most specific are 5.9, Assuring the Accuracy of Studies and Calibration Performance, in particular Subsection B, Participation in Interlaboratory Analysis, or Programs of Professional Research. Most accreditation bodies are very specific about the type of proficiency programs that your laboratory is involved in. Subsection B, therefore, allows the capability agency that you are dealing with to carry out its operations in accordance with ISO / IEC Guide 43. Acting with some other company will contribute to failure to comply.
With the calibration/inspection of measurement instruments, we know that the device is running correctly “since you can not get reliable goods if the technology used to measure them is not as thorough as practicable.
In the case of laboratories which are only certified by the ISO 17025 norm, the organizational benefits are the probability to traceability of all the research and facilities, and also the operational definition of the laboratory, which ensures that the results are reliable and valid. In this situation, there is an important advantage that is the higher level of preparation for people working in the laboratory.
The laboratory certification brings greater systematization of all the knowledge and events for the organization ISO 9001. Citizens become more interested and more constructive. There is also better training and details for staff.
Another great benefit for laboratories is the need to calibrate/check the measuring equipment while they conduct in-house services because the measuring equipment is crucial in evaluating the quality of the products.
What happens when you get certified?
The list below sets out the ISO/IEC 17025 accreditation processes:
- Complete the File Application
- Receiving Your Quote
- Enter Into A Contract
- Preparing for Accreditation
- Documentation Review
- Preliminary Assessment (This is optional)
- Opening Meeting (The Entry Briefing)
- The Accreditation Assessment
- The Closing Meeting (The Exit Briefing)
- Corrective Action Implemented
- Executive Committee’s Final Decision
- Accreditation Certificate Received
- Surveillance Of Assessments
Proof of excellence is important for laboratories that deliver the products of research and calibration. And the ISO / IEC 17025 certification is structured to help you set the required administrative and technological standards for consistent performance. Accreditation for your laboratory ensures that you have the appropriate compliance processes in place to handle everything from governance to operational activities. And all that can be accomplished by selecting ISO Pros to implement your ISO / IEC 17025 accreditation. We help you show to clients, regulatory agencies, and accreditation bodies that the laboratory satisfies ISO / IEC 17025 standards – beginning with an introduction to laboratory accreditation, developing and auditing the own enforcement program.
Suppliers needing accurate validation backed by a quality system will search for laboratories certified to ISO 17025. And that accreditation will come from an organization recognized under the mutual recognition agreement or MRA of the ILAC. Such partnerships aim to create a network of accreditation bodies whose research is known all over the globe. It is normal for businesses that do more than just laboratory services to get ISO 9001 approved without getting an ISO 17025 accredited laboratory.
With the recognized support of international organizations, ISO Pros will be able to provide tremendous marketing and business advantages to your laboratories, especially those with foreign business interests. So contact our team today about getting certified in Laboratory Accreditation ISO 17025. They are waiting to assist you with any questions you have and make sure your accreditation goes as smoothly as possible. ISO Pros is the company you can trust to deliver the first time, every time.